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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Internal cross reference: complaint pr# (b)(4).
 
Event Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that they cannot hear sound from the scan room.If the operator is unable to hear the patient due to a failed microphone, there is potential for injury to the patient.This issue has been determined to be a reportable event.This issue is currently under investigation.
 
Manufacturer Narrative
The customer reported that they could not hear sound from the patient in the scan room.This issue occurred on a brilliance 64 ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site to evaluate the system.The fse confirmed the customer allegation that sound could not be heard coming from the scanner microphones.The fse checked the hardware of the microphone in the gantry and determined that the gantry microphone had failed.The gantry microphone assembly was then replaced to correct the issue.The system is operational and in clinical use.This event has been determined not to be a reportable event.
 
Manufacturer Narrative
The customer reported that they could not hear sound from the patient in the scan room.This issue occurred on a brilliance 64 ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site to evaluate the system.The fse confirmed the customer allegation that sound could not be heard coming from the scanner microphones.The fse checked the hardware of the microphone in the gantry and determined that the gantry microphone had failed.The gantry microphone assembly was then replaced to correct the issue.The system is operational and in clinical use.This event has been determined not to be a reportable event.
 
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Brand Name
BRILLIANCE AIR 40/64/UCT
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 miner rd
cleveland OH 44143
MDR Report Key7153841
MDR Text Key96123409
Report Number1525965-2017-00162
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/05/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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